Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia

Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03025932

Enrollment

200

Registered

2017-01-20

Start date

2016-01-01

Completion date

2027-01-31

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiatal Hernia Large

Brief summary

Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.

Interventions

PROCEDURErepair of giant hiatal hernia with mesh and anterior fundoplication

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age older than 18 years * Initially suffering from large hiatal hernia (\>20% of the stomach in the thoracic cavity) * Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication * Informed Consent as documented by signature (Appendix: Informed Consent Form)

Exclusion criteria

* Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication * Performance of anterior fundoplication without mesh * Women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study

Design outcomes

Primary

Measure	Time frame	Description
Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan	minimum 1 year after surgery	To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography

Secondary

Measure	Time frame	Description
Quality of life by GIQLI	minimum 1 year after surgery	Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery
Clinical outcome	minimum 1 year after surgery	Evaluate the clinical outcome at least one year after surgery by examining the patient and asking targeted questions on the symptoms regarding the former hiatal hernia (using visual analogue scale questions on dysphagia, meteorism, bloating, reflux and retrosternal pain). Furthermore the patients are asked about their general satisfaction regarding the performed surgical intervention.
Peri- and postoperative morbidity / mortality	minimum 1 year after surgery	Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination

Contacts

PRINCIPAL_INVESTIGATORUrs Zingg

Principal Investigator

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026